112 results
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20ms
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Sources: EU EUDAMED, US FDA
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
FDA Enforcement
Class II
·Ongoing·Medica Corporation·February 25, 2026
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
FDA Enforcement
Class II
·Ongoing·Nipro Medical Corporation·December 17, 2025
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
FDA Enforcement
Class II
·Ongoing·Noah Medical Corporation·December 3, 2025
FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Enforcement
Class II
·Ongoing·Atrium Medical Corporation·June 12, 2024
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
FDA Enforcement
Class II
·Ongoing·Ohio Medical Corporation·June 25, 2025
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·March 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·March 19, 2025
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·March 19, 2025
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·March 19, 2025